Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

August 15, 2025 updated by: InGeneron, Inc.

Healing Osteoarthritic Joints in the Wrist With Adult Adipose Derived Regenerative Cells

This is a prospective, randomized, double-blinded, active controlled, single site safety and efficacy study in subjects suffering from chronic wrist osteoarthritis comparing a single ADRC injection generated with the Transpose® RT system into the wrist.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The focus of this study is to investigate the therapeutic benefit of autologous adipose-derived regenerative cells in patients with wrist arthritis. The hypothesis of this trial is that the use of adult-adipose derived regenerative cells as a treatment of wrist arthritis will induce healing and decrease pain compared to the control group. With adult-adipose derived regenerative cell administration, the medical practitioner would anticipate a reduction in inflammation, acceleration in healing, decreased pain in patients post procedure, and increased function and strength in the affected wrist. Currently, no clinical studies have been constructed to determine the efficacy of ADRCs in wrist arthritis patients.

Subjects will fall into two categories: treatment group (20) and control group (20 subjects). The treatment group will undergo a small liposuction procedure and receive wrist osteoarthritis treatment with an ultrasound-guided injection of 5 ml adipose-derived stem cells (ADSCs) into the wrist. The control group will receive a 5 ml cortisone injection into the wrist.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford USD Medical Center
    • Texas
      • Houston, Texas, United States, 77041
        • HD Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males and females ages: 18 - 75.
  2. Clinical symptoms consistent with wrist osteoarthritis.
  3. Diagnosed with wrist osteoarthritis on radiographs.
  4. The ability of subjects to give appropriate consent or have a legally authorized representative available.

Exclusion Criteria:

  1. Subjects who have a documented history or presence of inflammatory arthritis, rheumatoid arthritis, severe osteoporosis, sepsis and chondrocalcinosis in the wrist
  2. Subjects who have a documented diagnosis of carpal tunnel syndrome.
  3. Insufficient amount of subcutaneous tissue to allow recovery of 100ml of lipoaspirate
  4. History of systemic malignant or local neoplasms on affected limb within last 5 years
  5. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)
  6. Subjects who have received a corticosteroid injection in the treatment site
  7. Subjects on an active regimen of chemotherapy
  8. Allergy to sodium citrate of any "caine" type of local anesthetic
  9. Subjects pregnant or breast feeding
  10. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of patient reported outcome instruments
  11. Subjects who have document allergy to radiographic guidance agents.
  12. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
  13. History of tobacco use within the last 3 months
  14. Subjects with documented with a history of alcohol or drug abuse
  15. Subjects who have a documented history of HIV, Hepatitis B, and Hepatitis C
  16. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adipose Derived Regenerative Cell group
Subjects in the treated group will receive an Adipose derived regenerative cells (ADRCs) injection into the wrist using a fluoroscopic-guided injection .
Device: adipose-derived stem cell injection
5 ml injection of adipose derived stem cells
Active Comparator: Corticosteroid group
Subjects in the active control group will receive a corticosteroid injection into the wrist using a fluoroscopic-guided injection.
Drug: Corticosteroid injection
5 ml injection of corticosteroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Incidence of Treatment-Emergent Adverse Events
Time Frame: 12 months
Subjects will be monitored for adverse events
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - Change in Pain Scores on the Visual Analog Scale (VAS)-pain Scale at All Follow-up Visits
Time Frame: 3, 6 and 12 months
Patient outcomes for pain will be recorded (line from 0: no pain to 100:worst pain)
3, 6 and 12 months
Efficacy - Change in Function Scores on the PROMIS at All Follow-up Visits
Time Frame: 3, 6 and 12 months
Patient outcomes for function will be recorded (line from 0:unable to do to 100: without any difficulty)
3, 6 and 12 months
Efficacy - Change in Function Scores on the QuickDASH at All Follow-up
Time Frame: 3, 6 and 12 months
Patient outcomes for function will be recorded (line from 0:no difficulty to 100:unable)
3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InGeneron, Inc.

Collaborators

Sanford Health

Investigators

  • Principal Investigator: Robert Vandermark, MD, Sanford Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2018

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 5, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (Actual)

April 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 20, 2025

Last Update Submitted That Met QC Criteria

August 15, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OAW-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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